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Renovia has received a nod from FDA for a next-generation pelvic digital therapeutic. The Boston-based company said the Ieva device is cleared for the strengthening of pelvic floor muscles and the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (UI) in women.
The next-generation leva Digital Therapeutic uses Renovia’s movement-based sensor and app technology to provide women real-time feedback as they perform their pelvic floor muscle exercises. The new leva Digital Therapeutic is based on the same mechanism of action and sensor technology found in current-generation leva Digital Therapeutic that has been shown to provide statistically significant improvement in objective pelvic floor muscle (PFM) performance measures, patient-reported UI symptom severity, and condition-specific quality of life.
The clearance comes hot on the heels of the company’s completion of a multi-center, pilot randomized controlled trial (RCT) using the next-generation leva Digital Therapeutic device. The study included sixty (60) subjects, with the control group performing traditional Kegel exercises. The company said that despite being a 60-subject pilot study, the study found statistically better results among leva users.
“We look forward to announcing and publishing the results of our pilot RCT in the coming months,” noted Samantha Pulliam, MD, CMO at Renovia. “In the meantime, we’re using those results to finalize the design of a larger multi-center RCT that we will launch in the first half of 2020. Renovia is focused on improving the standard of care for female pelvic floor disorders through innovative products supported by world-class clinical evidence. FDA clearance of the next generation of the leva Digital Therapeutic is one of many milestones that we believe will allow us to improve care for the millions of women who experience UI and other pelvic floor disorders.”
In August of 2018, Renovia brought in $43 million in a series B financing round to help with the development of its technology.